4th Sep 2007 07:03
Dechra Pharmaceuticals PLC04 September 2007 Issued by Citigate Dewe Rogerson Ltd, BirminghamDate: Tuesday, 4 September 2007 IMMEDIATE RELEASE Dechra(R) Pharmaceuticals PLC An International Veterinary Pharmaceutical Business Vetoryl(R) US - Development Update Dechra Pharmaceuticals PLC ("Dechra") is pleased to announce that the USA Foodand Drug Administration ("FDA") has granted Vetoryl Capsules a designation for aminor use in a major species ("MUMS") to treat hyperadrenocorticism due toadrenocorticol tumours in dogs, which account for approximately 15% of Cushingscases. This is the first such designation granted in the USA. The benefit of a MUMS designation is that conditional approval for this minorindication can be received prior to the submission of the efficacy section forthe full marketing authorisation. Dechra has also been notified that the FDAconsiders the safety section to be approved. As indicated in the Preliminary Results statement released today (4 September2007), the chemistry and manufacturing controls section ("CMC") has beensubmitted to the FDA for review. Marketing under the MUMS designation cancommence once the CMC section is approved. Therefore, it is likely that Dechrawill be able to launch the product for this minor indication ahead of managementexpectations. The application for the full marketing authorisation continues onschedule. Enquiries: Ian Page, Chief Executive Fiona Tooley, DirectorSimon Evans, Group Finance Director Keith Gabriel, Senior Account ManagerDechra Pharmaceuticals PLC Citigate Dewe RogersonToday: 0207 638 9571 Today: 0207 638 9571Mobile: 07775 642222 (IP) or 07775 642220 (SE) Mobile: 07785 703523 (FMT) or 07770 788624Thereafter: 01782 771100 Thereafter: 0121 455 [email protected] Notes to Editors Vetoryl Capsules is a novel and patented product for the treatment of Cushing'sdisease (excess cortisol or hyperadrenocorticism) in dogs. It is the onlylicensed product within the EU and is the only recognised safe and efficaciousveterinary product for the treatment of Cushing's disease around the world.Launched in the UK on a provisional marketing authorisation in September 2001,Vetoryl Capsules has since achieved full approval and has consistently increasedmarket penetration. It also achieved mutual recognition for approval within theEU in 2006 and has now been launched within all the key European territories. Inthe USA it is currently sold under an FDA waiver scheme. Dechra and the Dechra 'D' logo are registered Trade Marks of DechraPharmaceuticals PLC and Vetoryl is a registered Trade Mark of the Dechra Group. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
DPH.L